A Medical Device Daily
Mindray Medical International Limited (Shenzhen, China) said it has received FDA clearance for its DC-3 color ultrasound imaging system. The clearance comes in addition to China State Food and Drug Administration (SFDA) approval and CE mark granted earlier this year for the sale of the DC-3 in Chinese and European markets, respectively.
"The compact DC-3 combines outstanding 2-D imaging and exceptional color Doppler performance," said Li Xiting, Mindray's president/co-CEO. "With a superior price-to-performance ratio, we are confident that this versatile product will meet the diverse needs and requirements of hospitals, doctors' offices and veterinary clinics around the world."
The DC-3 color ultrasound imaging system is designed to have extensive applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets. The product is designed for U.S. hospitals, doctors' offices and veterinary clinics seeking to replace black and white ultrasound imaging systems. The company currently offers more than 10 medical imaging products, of which five have received FDA 510(k) clearance.
Mindray makes a broad range of products across three primary business segments: patient monitoring & life support products, in vitro diagnostic products and medical imaging systems.